Cleared Traditional

K040890 - 3M TEGADERM SILVER

K040890 · 3M Company · General & Plastic Surgery device
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Nov 2004
Decision
223d
Days
-
Risk

K040890 is an FDA 510(k) clearance for the 3M TEGADERM SILVER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on November 2, 2004 after a review of 223 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K040890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2004
Decision Date November 02, 2004
Days to Decision 223 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 115d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 221
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K040890.
MEDLINE IODOFORM PACKING STRIPS
K052720 · Medline Industries, Inc. · Oct 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164 · Medline Industries, Inc. · Jun 2005
ACTICOAT MOISTURE CONTROL DRESSING
K050030 · Smith & Nephew, Inc. · Apr 2005
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
K033869 · Coloplast Corp. · May 2004
CONTREET FOAM ADHESIVE/NON-ADHESIVE
K022416 · Coloplast Corp. · Feb 2003
ABSORBENT ANTIMICROBIAL WOUND DRESSING
K013814 · Convatec, A Division of E.R. Squibb & Sons · Jun 2002